# Dietary Biomarkers Development Center at Harvard University

> **NIH NIH U2C** · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · 2024 · $1,420,147

## Abstract

PROJECT SUMMARY - OVERALL: Accurate dietary assessments in free-living populations remain a major
challenge in nutrition research. In response to the RFA-DK-20-005, we propose to create a Dietary Biomarkers
Development Centers (DBDCs) at Harvard University. Our long-term goal is to establish a rigorous and highly
productive resource, available to the NIH, USDA, and external investigators, to systematically catalog validated
metabolomic signatures of intakes of foods/food groups defined by the USDA. Our Specific Aims are:
Aim 1. Establish an Administrative Core that will provide scientific leadership, administrative oversight, and
seamless coordination of the efforts of the participating Cores and Projects within and across DBDCs;
Aim 2. Establish an Intervention Core that will perform controlled pharmacokinetic (PK) and dose-response
feeding studies of: 1) chicken, beef, and soybeans; and 2) whole wheat bread, potatoes, and oats. The food
selection is based on their contributions to protein and carbohydrate intakes in the U.S. diets, their potential
health effects, and the promise of finding valid markers. Nonetheless, we are also receptive to testing different
foods or food groups in coordination with other DBDCs and the Steering Committee;
Aim 3. Establish a Metabolomics Core that will 1) use an integrated metabolomics platform of five
complementary high resolution and accurate LC-MS methods that together comprehensively profile food-
derived compounds with diverse chemical and physical properties in plasma and urine; 2) elucidate structures
of yet unidentified LC-MS metabolite peaks associated with food intake;
Aim 4. Establish a Data Analysis Core that will: 1) provide dedicated statistical support and expertise for all
Cores and the Biomarkers Project within the Center; and 2) manage and maintain large datasets and ensure
timely analytic tool/software sharing with other DBDCs and data submission to the Data Coordinating Center;
Aim 5. Conduct a Biomarkers Project by integrating Core resources to 1) characterize pharmacokinetics and
establish calibration curves of novel food biomarkers using data from the controlled feeding studies; 2)
evaluate the identified biomarkers’ performance in an already completed 6-week controlled feeding trial of
three healthy dietary patterns (OmniHeart); and 3) validate the identified dietary intake biomarkers in two
observational cohorts with repeated measures of diet, nutrient biomarkers, metabolome, and gut microbiome.
The proposed DBDC at Harvard is carefully structured and highly integrated, taking a systemic and innovative
approach to dietary biomarker discovery and validation. Our metabolomics platform has contributed data to
NIH consortia, including Integrative Human Microbiome Project (iHMP), Molecular Transducers of Physical
Activity Consortium (MoTrPAC), and Trans-Omics for Precision Medicine (TOPMed) program. By leveraging
multiple areas of expertise and the exceptional resources, we will contribute t...

## Key facts

- **NIH application ID:** 10898076
- **Project number:** 5U2CDK129670-04
- **Recipient organization:** HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH
- **Principal Investigator:** Clary B Clish
- **Activity code:** U2C (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,420,147
- **Award type:** 5
- **Project period:** 2021-08-16 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10898076

## Citation

> US National Institutes of Health, RePORTER application 10898076, Dietary Biomarkers Development Center at Harvard University (5U2CDK129670-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10898076. Licensed CC0.

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